Summary of Product Characteristics
last updated on the eMC:
06/08/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 06/08/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 28-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5
Update to section to include poor bioavailability of certain anti-malaria drugs, Chloroquinine included, associated with concomitant therapy with antacids/adsorbents:
Change of text in first and second paragraph (note the text has been moved in the section)
If the patient is taking amiodarone then chloroquine and hydroxychloroquine may increase the risk of cardiac arrhythmias including ventricular arrhythmias, bradycardias and cardiac conduction defect. Concurrent use is contraindicated.
Antacids (aluminium, calcium and magnesium salts) and adsorbents (e.g. kaolin) may reduce the absorption of chloroquine, so should be taken well separated from Avloclor (at least four hours apart).
Section 10
Revision date of text: 28 July 2009
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Updated on 20/06/2005 and displayed until 06/08/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 12/06/2003 and displayed until 20/06/2005
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 09/11/2001 and displayed until 12/06/2003
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 12/10/2001 and displayed until 09/11/2001
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Updated on 24/08/2001 and displayed until 12/10/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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Updated on 06/09/1999 and displayed until 24/08/2001
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Reasons for adding or updating:
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